Clinical studies
Clinical bioequivalence and bioavailability study sponsorship can be a significant burden for pharmaceutical companies. That’s because sponsorship demands that companies adhere to strict ethical and scientific quality standards (according to ICH guidelines for good clinical practice E6 and CTR 536/2014). More specifically, pharmaceutical companies sponsoring a clinical study must create and maintain a risk-based quality assurance system, which includes:
- Ensuring compliance with standard operating procedures (SOPs)
- Qualifying contractors
- Conducting complex audits
- Serving good clinical practice (GCP) inspections
- Managing deviations and corrective and preventive actions (CAPAs)
- Managing and archiving all associated documentation
Moreover, they need to build and maintain up-to-date scientific and clinical knowledge as well as oversee clinical study project management. Meeting these responsibilities requires extensive in-house resources and deep expertise. But engaging a full-service CDMO with the ability to act as sponsor of clinical studies offers an attractive solution.
Full-service support by HERMES PHARMA – including scientific and clinical (GCP) services
As a true full-service provider, HERMES PHARMA can help: We can act as the sponsor of clinical studies for bioequivalence/bioavailability (BE/BA) during the development of generic products. We can also manage efficacy studies on food for special medical purposes (FSMP).
Our services include:
- Development of clinical and regulatory strategies (for example, identifying a suitable reference product) to maximize chances of study success
- Creating and maintaining a Good Clinical Practice (GCP) quality system in accordance with strict regulatory requirements
- Provision of a dedicated project management team to supervise the clinical studies
- Preparation of investigational medicinal product dossiers (IMPDs) for the approval of clinical trials by EU authorities
- Consulting and scientific advice on study strategy and design
HERMES PHARMA can also provide everything needed to supply clinical samples for BE/BA studies, including: production, labelling, and testing of investigational medicinal products (IMPs); analysis of dissolution profiles of test and reference IMPs; applying a Good Manufacturing Practice (GMP) quality system to ensure IMPs are safe and effective; and the release of IMPs by a qualified person (QP).
The benefits for pharmaceutical companies
+ No legal responsibility for clinical study oversight
You won’t need to establish the required quality assurance system or build out clinical and regulatory expertise in-house, relieving the burden on your in-house team and saving time, money, and effort.
+ Simplified project management
Work with a single partner from product concept through to product launch and manufacturing, streamlining project coordination.
+ A flexible partnership
HERMES PHARMA is a flexible and agile organization that can seamlessly pivot to meet your needs.
+ Faster development, higher chance of success
HERMES PHARMA’s medical and regulatory experts collaborate on comprehensive clinical and regulatory strategies. By managing the entire development process, we optimize each stage, increasing clinical study success likelihood and reducing risk.
Why choose HERMES PHARMA as CDMO and sponsor for bioequivalence and bioavailability studies?
HERMES PHARMA has a 100+ year legacy of pharmaceutical excellence, with the deep expertise and customer-centric commitment needed to help its customers deliver high-quality, user-friendly pharmaceutical products to market. Our experience in clinical studies, and our knowledge of how to optimize earlier development steps for maximum chances of success at the clinic, mean we are optimally placed to support your project from concept through to market release.